Researchers are not doing enough to recruit women when it comes to participation in clinical trials, according to FDA Commissioner Mark McClellan, MD. McClellan told members of the Society for Women's Health Research (Washington) recently that its important that clinical research include greater numbers of women so that more information is gained concerning how a drug or device interacts with females. The agency completed a guidance document in September on the collection of race and ethnicity data in clinical trials, and that document also emphasizes the importance of including women in clinical research, he said. "Although FDA has long requested race and ethnicity data as well as inclusion of females in certain clinical trials the agency is now making recommendations on the categories to use when collecting and reporting data."

McClellan's remarks were welcomed by the society, which is lobbying members of Congress to pass the Genetic Information Nondiscrimination Act. The bill would prevent insurers and employers from using an individual's genetic predisposition to a disease as a basis for denying them health coverage or a job. More importantly, patients and women in particular would be reluctant to participate in clinical trials or forgo life-saving treatments for fear that their genetic information would be used as a basis for discriminating against them in health insurance or employment, the organization argues.

There are several historical reasons women have been excluded from clinical trials, according to society chair Denise Faustman, MD, associate professor of medicine at Harvard Medical School and director of the immunology laboratory at Massachusetts General Hospital (both Boston, Massachusetts). First, researchers claim difficulty in recruiting and retaining women in clinical trials, she said. Secondly, there are concerns about the potentially confounding effects of a woman's hormonal changes on the treatment being studied. Third, Faustman said, there is a desire to protect a potential fetus. "There's the fear of liability issues if a fetus is harmfully exposed during research." And, she said, "there's the underlying assumption that a woman's body is essentially the same as a man's, only smaller."

But if a drug or device is not tested on women, there's no way to know if it is safe or effective for women, Faustman argued. "If clinical trials do not include women, the drug's effectiveness and side effects in women will only be discovered after the drug has been approved and is on the market. Inclusion of women at all stages of safety and efficacy testing of new drugs is crucial to ensuring that women receive appropriate care," she said.

The society conducted a study last spring that found most women over age 50 who had participated in a clinical research study would likely take part in a study again. The study was based on a survey of 1,017 American women, and respondents were asked if they had ever participated in a medical research study, as a healthy volunteer in an observational study, a patient in a clinical trial or as a participant in a long-term study. Less than 12% of women 50 and older had ever taken part in a clinical study, according to the study data. The results were promising, said Phyllis Greenberger, the society's president and chief executive officer, in that they underlined the need for more health information concerning older women. As the number of older American women grows and life expectancy increases, she said, specific information about disease prevention, diagnosis and treatment will be important.

Minority healthcare gaps to cost billions

Racial and ethnic minorities who fail to adequately manage their diabetes, hypertension or HIV/AIDS could end up compiling an excess healthcare tab of $331 billion over the next seven years, according to a study recently issued by the Corporate Value Consulting healthcare practice division of Standard & Poor's (New York). The report says that the additional costs comparing whites and minorities in the U.S. and calculated in terms of their medical expenses and lost productivity will have a heavy impact on taxpayers, patients and employers in the U.S.

The study, "Closing the Health Gap: An Economic Analysis," was developed to quantify the potential added costs when health is made a low priority among racial and ethnic minority populations. The analysis coincides with an educational project by the U.S. Department of Health and Human Services (HHS; Washington) called "Close the Health Gap." Gary Brewster, director in the Corporate Value Consulting division of Standard & Poor's and co-author of the study, told The BBI Newsletter, "We undertook this research because we are impressed with the aims of the HHS 'Close the Gap' initiative and felt that it would be useful to develop an economic picture of the health gap." To reach their conclusions, Brewster said the researchers analyzed existing literature and conducted a valuation analysis of the costs for direct medical attention, such as physician visits, medication and hospitalization, plus lost productivity due to disability and premature mortality.

The total cost of the gap in health costs between whites and minorities for diabetes, hypertension and HIV/AIDS in 2002 was estimated at $35.8 billion, they concluded. Total costs of disease gaps by breakdown are as follows: diabetes, $19.1 billion; hypertension, $8.5 billion; HIV/AIDS, $11 billion. The overlapping effect of diabetes combined with hypertension adds an additional $2.8 billion to the total, the researchers found. While numerous studies and articles have focused on the differences in disease and disease outcomes between whites and minorities, the researchers noted, "none have specifically quantified the economic cost of the health gap. This type of knowledge is crucial, as it will support policy makers, whether corporate executives or public officials, in making important resource allocation decisions affecting shareholders, employees, or taxpayers."

"As a firm that specializes in industry-focused valuation analyses, we felt that an economic perspective could improve understanding and provide information to policy makers, both public and private, as they pursue better ways to address these disparities," Brewster said. "We expect that further analysis will explore additional populations, diseases, and cost categories to gain a more complete picture."

Although the study does not address the issue of the rising number of uninsured in the U.S., Brewster noted that racial and ethnic minorities who are uninsured would increase costs in the healthcare gap for acute care. "If they are uninsured, the costs would certainly be borne by taxpayers for hospitalizations and emergency room visits," he said. The researchers said additional research is needed to determine if encouraging physician visits achieves potential economic savings. More effort needs to be made to focus on individual programs, said Brewster. "If minorities and racial groups visit a physician more often and there's an economic benefit from that visit, we need to find out why they are returning to the physician so the program can be replicated," he said.

Indiana Future Fund is established

A coalition of institutional investors has announced the formation of Indiana Future Fund I, with hopes that it will fuel an expansion of venture capital activity in Indiana. The fund is a $72 million capital pool that will invest in regional and national venture capital funds, encouraging direct investment in Indiana life sciences opportunities. Indiana Future Fund I is organized through BioCrossroads, Central Indiana's life sciences initiative, and managed by Credit Suisse First Boston (CSFB). Investments have come from Indiana's public pension funds, Eli Lilly and Co., Anthem Blue Cross and Blue Shield, Indiana University, Indiana University Foundation, Purdue University, Ball State University Foundation, American United Life Insurance Co., Indiana State University Foundation and Guidant.

"It's often been said that Indiana has a wealth of intellectual property in the life sciences, but we've lacked the capital to bring ideas to market here. This announcement is the first step toward changing all that," said David Johnson, chairman of the BioCrossroads Capital Formation Committee. "The Indiana Future Fund represents a huge vote of confidence by many of Indiana's leading institutions in our future as a center for life sciences," Johnson told BBI's sister publication, Medical Device Daily. He said that what makes this fund different from others is that it has "three distinctly different types of investors in it." A key group is the state pension funds, which only recently have been allowed to invest in private equity in Indiana. "They are primarily focused on the return," Johnson said. "The goal is to be in the top quartile of similarly pledged venture managers, which would be 500 basis points above the S&P 500 healthcare index." That, he said, "translates into a pretty high rate of return [of] 18% to 20% over a 10-year period. That's what [the pension funds] are looking for."

"Indiana has the nation's fifth-largest pharmaceutical and medical devices economy," said Gov. Joe Kernan in a statement. "We have a unique opportunity now, with cooperation between the public, private and academic sectors, to leverage this strength on behalf of Hoosier entrepreneurs."

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